Evaluating efzofitimod for lung disease related to systemic sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is designed to assess the efficacy, safety, and tolerability of efzofitimod in patients suffering from interstitial lung disease associated with systemic sclerosis. It consists of two parts: a double-blind, randomized, placebo-controlled phase where participants will receive either efzofitimod or a placebo for 20 weeks, followed by an optional open-label extension for those who complete Part A. The study aims to measure improvements in lung function and skin condition in participants diagnosed with systemic sclerosis-related interstitial lung disease.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Diagnosis of SSc based on ACR/ EULAR criteria (2013)
2. Overall duration of SSc \< 84 months from the first non-Raynaud symptom manifestation prior to Day 1
3. HRCT obtained at the Screening Visit or within the 3 months prior to Screening consistent with SSc-ILD (adjudicated by a central reader) AND with pulmonary involvement \> 10%
4. Clinical presentation at Screening consistent with lcSSc (up to 40% of patients) or dcSSc
5. MMF of ≥ 2 gm/day (or equivalent doses of other mycophenolate based compounds) for 3 months prior to Day 1 OR When documented intolerance to mycophenolates (in discussion with the Medical Monitor): treatment with maximum tolerated dose of MMF is acceptable, if \< 2 gm/day, provided the cumulative duration of dosing has exceeded 3 months, OR An adequate dose and duration of an alternate immunosuppressant with a stable dose for the 4 weeks prior to baseline is also allowed.

Exclusion Criteria:

1. Pulmonary disease with FVC %pred ≤ 45% OR DLco %pred ≤ 30%; FEV1/FVC ratio \< 0.7
2. Participants with pulmonary artery hypertension on parenteral therapy or with clinical evidence of right heart failure
3. HRCT obtained in the 3 months prior to Screening consistent with other confounding pathology.
4. Treatment with corticosteroids (\> 10 mg/day of prednisone or equivalent) within 2 weeks prior to Day 1
5. Treatment with more than 1 immunosuppressant (e.g., MMF, methotrexate \[MTX\], azathioprine \[AZA\], or leflunomide)
6. Any treatment in the 12 months prior to Day 1 with any of the following: rituximab, intravenous immune globulin (IVIG), tocilizumab, cyclophosphamide, pirfenidone, tyrosine-kinase inhibitors (e.g., imatinib, nilotinib, dasatinib)
7. Rheumatic autoimmune disease other than SSc, Is an active, heavy smoker of tobacco/nicotine-containing products
8. History of (anti-Jo-1) anti-synthetase syndrome or Jo-1 positive at Screening

Where it's running

• aTyr Investigative Site
  Los Angeles, California, United States Recruiting
• aTyr Investigative Site
  San Diego, California, United States Recruiting
• aTyr Investigative Site
  Miami, Florida, United States Recruiting
• aTyr Investigative Site
  Chicago, Illinois, United States Recruiting
• aTyr Investigative Site
  Chicago, Illinois, United States Recruiting
• aTyr Investigative Site
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: aTyr Pharma Clinical Research
• Email: clinicaltrials@atyrpharma.com
• Phone: 877-215-5731

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Telitacicept for primary Sjögren’s with interstitial lung disease

  This study tests whether Telitacicept helps people with primary Sjögren’s syndrome and interstitial lung disease compared with standard immunosuppressants.

  Recruiting Peking University People's Hospital · Beijing · NCT07843381

• Inhaled mosliciguat for pulmonary hypertension in interstitial lung disease (PH-ILD) patients

  This study tests inhaled mosliciguat versus placebo in people with PH-ILD to see if it helps with their condition.

  Recruiting at 3 sites Phase 3 Pulmovant, Inc. · Kissimmee, Florida and 2 other locations · NCT07816185

• Treprostinil Palmitil Inhalation Powder for Progressive Pulmonary Fibrosis

  A 52-week study will test whether once-daily Treprostinil Palmitil Inhalation Powder helps lung function in adults with progressive pulmonary fibrosis compared to placebo.

  Recruiting Phase 3 Insmed Incorporated · DuBois, Pennsylvania · NCT07805785

• Treatment Response in Myositis-Associated RP-ILD in Adults

  This study tests how people with myositis and rapidly progressing interstitial lung disease respond to an immunosuppressant treatment approach.

  Recruiting Singapore General Hospital · Singapore · NCT07775235

• AccuPulmo CT Portal for Detecting Pulmonary Fibrosis on Chest CT

  This study tests how well the AccuPulmo CT Portal can identify pulmonary fibrosis on existing chest CT scans from adults at Taichung Veterans General Hospital.

  Recruiting Taichung Veterans General Hospital · Taichung · NCT07761377

• See if 18F-FAPI-74 PET/CT can better detect fibrosis in heart and lung disease

  Researchers are testing a new PET/CT tracer, 18F-FAPI-74, to see if it can reveal early fibrotic changes in people with heart and lung diseases who are at risk for tissue scarring.

  Recruiting Phase 3 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07613099

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.